As a manufacturer, do you want to have your dental cements analyzed?
Why analyze dental cement?
Dental cement is a medical device whose risks must be assessed and biocompatibility controlled before being placed on the market. These analysis of dental cement as a medical device are governed by ISO 10993, more specifically ISO 10993-18 concerning biocompatibility.
FILAB laboratory supports you in analyzing the biocompatibility of dental cements
Dental cement analysis techniques as a medical device
Originally, ISO 9917-1:2003 specified the requirements and test methods for liquid/powder acid-base dental cements intended for use in luting or lining applications.
However, this standard does not specify qualitative or quantitative requirements concerning the absence of biological risks. For this reason, dental cements must be analyzed in the same way as other medical devices, in accordance with ISO 10993, and more specifically ISO 10993-18. FILAB laboratory therefore makes its expertise available to you for:
- The characterization of ceramics used in medical devices such as dental cement according to ISO 10993-18
- The identification and quantification of ceramic degradation products according to ISO 10993-14
- Analysis of cleaning residues, HCT/TOC
- Analysis of nanomaterials present in medical devices according to ISO 10993-22
Why choose FILAB for dental cement analysis?
FILAB laboratory is the first French laboratory accredited by COFRAC ISO 17025 for nanometric characterization according to ISO 10993-22. Our team of highly qualified experts is available to support you in analyzing your dental cements and medical devices. With our 2,100 m² analytical facility, we adapt our techniques to your medical device, not the other way around. Our service offering is tailor-made to meet the specific needs of your industry.
